Tu Chi-Ming
1 Food and Drug Administration, Center for Drug Evaluation and Research/ Office of Surveillance and Epidemiology/Office of Medication Error Prevention and Risk Management/ Division of Medication Error Prevention and Analysis, Silver Spring, MD, USA.
Ther Innov Regul Sci. 2019 Jan;53(1):132-137. doi: 10.1177/2168479018762376. Epub 2018 Apr 22.
To identify if proprietary names are used by health care practitioners when prescribing over-the-counter (OTC) drug products. These findings can inform evaluation of proposed proprietary names for both prescription and OTC drug products.
QuintilesIMS OTC International Market Tracking (QuintilesIMS OTCIMS) was used to identify top OTC drug products sold to the consumers from US retail store outlets in year 2011. QuintilesIMS's Vector One: National (VONA) was used to identify prescribers' use of proprietary names by examining drug use data from 2003 to 2011 for the top OTC products identified from QuintilesIMS OTCIMS.
Of the 29 OTC drug products that have drug utilization data available, the data showed prescribers' use of proprietary names every year from 2003 to 2011 for 24 OTC drug products, and from 2004 to 2011 for 2 OTC drug products. The drug use data showed the use of proprietary name in some years but not all years from 2003 to 2011 for the remaining 3 OTC drug products. For the OTC drug products studied, prescribers used proprietary names for OTC products when prescribing them, and the use of proprietary names on prescriptions can vary during a 9-year period.
This research identified that prescribers do prescribe OTC drug products using proprietary names. This prescribing practice confirms the need for the pharmaceutical industry, industry consultants, and regulators to consider the proprietary names of OTC drug products when formulating and evaluating new proprietary names for drugs.
确定医疗保健从业者在开具非处方药（OTC）产品处方时是否使用商品名。这些发现可为评估处方药和非处方药产品的拟用商品名提供参考。
使用昆泰IMS非处方药国际市场跟踪系统（QuintilesIMS OTCIMS）来确定2011年在美国零售商店向消费者销售的顶级非处方药产品。通过检查昆泰IMS OTCIMS确定的顶级非处方药产品在2003年至2011年的用药数据，使用昆泰IMS的Vector One：National（VONA）来确定开处方者对商品名的使用情况。
在有药物利用数据的29种非处方药产品中，数据显示，在2003年至2011年期间，有24种非处方药产品的开处方者每年都使用商品名，在2004年至2011年期间，有2种非处方药产品的开处方者每年都使用商品名。对于其余3种非处方药产品，药物使用数据显示在2003年至2011年的某些年份使用了商品名，但并非所有年份都使用。对于所研究的非处方药产品，开处方者在开具非处方药产品处方时使用商品名，并且在9年期间，处方上商品名的使用情况可能会有所不同。
本研究确定开处方者确实会使用商品名开具非处方药产品。这种开处方做法证实了制药行业、行业顾问和监管机构在制定和评估新的药品商品名时需要考虑非处方药产品的商品名。
